Job Description:

The Clinical Trial Manager (CTM) position will provide support and/or leadership for one or more global cross-functional clinical studies (includes First-in-Human, proof-of-concept, dose-ranging, special populations Phase II trials). Experience working in a fast-paced, highly dynamic biotech environment is desirable. The CTM is accountable for ensuring clinical trial activities and deliverables within Company and with external vendors are completed on-time and within budget in accordance with the appropriate quality standards including GCP/ICH requirements and applicable international regulations.

Job description and technical requirements:

• Oversee the daily operations of one or more clinical studies including project planning, budget, resource management, and CRO and clinical vendor management.
• Adhere to project timelines and budgets.
• Perform study management activities, including, budget and contract negotiations, study material creation, enrollment tracking/oversight, and report review.
• Develop study related documents and provides guidance for the clinical sites to establish protocol adherence.
• Write routine and ad hoc project updates, as needed, and coordinate project meetings, information, and timelines to assure deadlines are achieved.
• Report study progress/timelines, program updates, achievements, and potential issues/risks to Senior Management.
• Ensure that the conduct of clinical trials is in compliance with ICH, GCP and applicable regulatory requirements and that reported trial data are accurate, complete, and verifiable from source documentation.
• Participate in the assessment and selection of vendors such as CROs, central laboratories, and other specialty service providers, as needed.
• Identification and selection of clinical investigators and study sites.
• Work closely with CRO monitoring team to ensure data entry and site monitoring practices are in line with study requirements.
• Comprehensive understanding of and experience in the drug development process is required including initiation procedures, clinical monitoring functions, drug safety reporting, data flow from external sites to internal processing/review/query resolution, data analysis, and study report generation.
• Represent the company with a high level of integrity and professionalism.
• Adherence to company’s policies and support management decisions and goals in a positive, professional manner.
• Able to recognize need(s), find solutions and take initiative to address in pro-active manner.
• Excellent interpersonal and professional skills are mandatory.
• Strong organizational and time management skills.
• Experience with influencing and negotiating to achieve team delivery; flexible, proactive, and solution-focused.
• Excellent planning and organizational skills.
• High level of initiative and ability to work independently; self-motivated and achievement driven.
• Strong research and analytical skills.
• Able to distill complex information from multiple sources and draw meaningful conclusions and insights.
• Ability to travel domestically and internationally may be required.
• May mentor/supervise junior team members.
• Perform other duties as assigned.
  

Qualifications and Experience:

• Bachelor’s or equivalent degree in biological science, pharmacy or other health related discipline
• At least five (5) years of Clinical Operations / Clinical Development experience, with 2 years managing clinical trials.
• Phase 1-2 clinical study experience is required, phase 3 experience desired.
• Biotech experience preferred.
• Respiratory and/or infectious disease experience preferred.
• Strong computer skills, including but not limited to the working knowledge of clinical trial management systems (CTMS), electronic document management systems (EDMS), electronic data capture systems (EDC), use of MS-Office products such as PowerPoint, Excel and Word, and experience with Microsoft Project or other timeline software required.

• Highly effective verbal, presentation, and written communication skills; adjusts content and style for audience; effectively delivers key messages; able to manage and communicate with cross-functional teams and stake holders. Fluency in English is required.

• Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
• Thorough knowledge of medical terminology.
• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
• Able to develop tools and processes that increase the measured efficiencies of the project, and must be able to anticipate obstacles and proactively develop solutions to achieve project goals.

 

 

Posted On: Thursday, April 25, 2024